Pharmaceutical compositions for the coordinated delivery of NSAIDs
View Patent ↗The present invention is directed to drug dosage forms that release an agent that raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal anti-inflammatory drug. The dosage form is designed so that the NSAID is not released until the intragastric pH has been raised to a safe level. The invention also encompasses methods of treating patients by administering this coordinated release, gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain and symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions and hemorrhages.
1. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of:
(a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and
(b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher wherein said coating comprises methacrylic acid copolymers;
wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.
2. The pharmaceutical composition of claim 1 , wherein naproxen is present in said unit dosage form in an amount of 200-600 mg.
3. The pharmaceutical composition of claim 1 , wherein esomeprazole is present in said unit dosage form in an amount of from 5 to 100 mg.
4. The pharmaceutical composition of claim 1 , wherein naproxen is present in said unit dosage form in an amount of between 200-600 mg and esomeprazole in an amount of from 5 to 100 mg per unit dosage form.